Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Lidocaine 4% ...... Purpose: Topical Anesthetic
OTC - PURPOSE SECTION
Topical Anesthetic
41cb1135-84e0-0c9a-e063-6294a90ada96
- Set ID
- 41cb1135-84e0-0c9a-e063-6294a90ada96
- Manufacturer
- Medhome Pharma Inc
- Effective date
- 2025-10-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:40:05
Key Label Information
Uses
INDICATIONS & USAGE SECTION
Adult and Children 12 years of age and over: Clean and dry affected area Remove film from patch and apply to the skin (see illustration) Apply 1 patch at a time to affected area, not more than 3 to 4 times daily Remove patch from the skin after at most 8-hour application Children under 12 years of age: Consult a doctor
Warnings
WARNINGS SECTION
For external use only
OTC - DO NOT USE SECTION
More than 1 patch at a time On wounds or damaged skin With a heating pad If you are allergic to any ingredients of this product
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, ask a health professional before use
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
This is a strip, patch dosage form. The active ingredient strength is 4% w/w. One patch one time, no more than 8 hours one time.
Other Label Information
INACTIVE INGREDIENT SECTION
Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water
OTC - QUESTIONS SECTION
E-mail：CS@pharmacychoiceUSA.com
Products
- PAIN RELIEVING
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| METHYLPARABEN | A2I8C7HI9T | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| SODIUM POLYACRYLATE (2500000 MW) | 05I15JNI2J | IACT |
| WATER | 059QF0KO0R | IACT |
| DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS | 1K713C615K | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYACRYLIC ACID (250000 MW) | 9G2MAD7J6W | IACT |
| KAOLIN | 24H4NWX5CO | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| POVIDONE K90 | RDH86HJV5Z | IACT |
Complete SPL Sections
OTC - ACTIVE INGREDIENT SECTION
Lidocaine 4% ...... Purpose: Topical Anesthetic
OTC - PURPOSE SECTION
Topical Anesthetic
USE IN SPECIFIC POPULATIONS SECTION
For temporary relief of pain
WARNINGS SECTION
For external use only
OTC - ASK DOCTOR/PHARMACIST SECTION
localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering Conditions worsen Symptoms persists for more than 7 days Symptoms clear up and occur again within a few days
OTC - WHEN USING SECTION
Use only as directed Avoid contact with the eyes, mucous membranes or rashed Do not bandage tightly
OTC - DO NOT USE SECTION
More than 1 patch at a time On wounds or damaged skin With a heating pad If you are allergic to any ingredients of this product
OTC - STOP USE SECTION
localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering Conditions worsen Symptoms persists for more than 7 days Symptoms clear up and occur again within a few days
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE SECTION
Adult and Children 12 years of age and over: Clean and dry affected area Remove film from patch and apply to the skin (see illustration) Apply 1 patch at a time to affected area, not more than 3 to 4 times daily Remove patch from the skin after at most 8-hour application Children under 12 years of age: Consult a doctor
DOSAGE & ADMINISTRATION SECTION
This is a strip, patch dosage form. The active ingredient strength is 4% w/w. One patch one time, no more than 8 hours one time.
INACTIVE INGREDIENT SECTION
Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water
OTC - QUESTIONS SECTION
E-mail：CS@pharmacychoiceUSA.com
OTHER SAFETY INFORMATION
Avoid storing product in direct sunlight Protect product from excessive moisture
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/41cb1135-84e0-0c9a-e063-6294a90ada96/41cb1135-84e1-0c9a-e063-6294a90ada96.xml
- XML SHA-256
- 4726238b30ad7a777f3a453d5b88e6aed56b93dcd7321498c6e22cee9d839a84
- XML bytes
- 24498
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 15.jpg | 2025-10-27 |
| otc | 30.jpg | 2025-10-27 |
| otc | 41cb1135-84e1-0c9a-e063-6294a90ada96.xml | 2025-10-27 |